AzTrials
AzTrials

Uncontrolled HypertensionHTN-2NCT00888433

Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

A study testing Renal Denervation (Symplicity® Renal Denervation System) in people with Uncontrolled Hypertension, run by Medtronic Vascular at 20 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Uncontrolled Hypertension
What is being tested?
Renal Denervation (Symplicity® Renal Denervation System)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
20 sitesin 10 countries
Study dates
Jun 2009to May 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
  • on 3 or more antihypertensive medications
  • >= 18 and =< 85 years of age.

Who cannot join

  • renal artery abnormalities
  • eGFR < 45mL/min
  • MI, angina, CVA within 6 months
  • Type 1 diabetes
  • ICD or pacemaker, or any other metallic implant not compatible with MRI
  • others

Trial locations and contacts

20 sites in 10 countries.

20 sites in 10 countries

Germany9 sites

  • Herzzentrum Bad Krozingen

    Bad Krozingen

  • Universität zu Köln

    Cologne

  • Universitaetsklinikum Dusseldorf

    Düsseldorf

  • University of Erlangen at Nuremburg

    Erlangen

  • Universitaetsklinikum Essen

    Essen

  • CardioVascular Center Frankfurt

    Frankfurt

  • Universitatskliniken des Saarlandes

    Homburg

  • University of Leipzig - Herzzentrum

    Leipzig

  • Universitatsklinikum Schleswig-Holstein, Luebeck Campus

    Leubeck

Other trials in Germany

United Kingdom3 sites

  • Kent and Canterbury Hospital

    Canterbury

  • University of Glasgow

    Glasgow

  • Barts and the London School of Dentistry & Medicine

    London

Other trials in United Kingdom

Australia1 site

  • Alfred Hospital

    Melbourne

Other trials in Australia

Austria1 site

  • Vienna General Hospital

    Vienna

Other trials in Austria

Belgium1 site

  • Cliniques Universitaires Saint Luc

    Brussels

Other trials in Belgium

France1 site

  • Hopital Européen Georges Pompidou

    Paris

Other trials in France

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga

Other trials in Latvia

Poland1 site

  • Samodzielna Pracownia Hemodynamiczna

    Warsaw

Other trials in Poland

Spain1 site

  • Hospital 12 de Octubre

    Madrid

Other trials in Spain

Switzerland1 site

  • Universitaatsspital Zurich

    Zurich

Other trials in Switzerland

About this study

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Being tested
Renal Denervation (Symplicity® Renal Denervation System)
Keywords
hypertension, renal denervation, sympathetic nervous system, RDN
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal Denervation (Symplicity® Renal Denervation System)Device

    Catheter-based renal denervation

Study groups in NCT00888433
Study groupRoleWhat they receive
Renal DenervationExperimentalRenal Denervation and maintenance of anti-hypertensive medications
Receives: Device: Renal Denervation (Symplicity® Renal Denervation System)
ControlNo interventionMaintenance of anti-hypertensive medications with option for cross-over treatment after 6-months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Office Systolic Blood Pressure Reduction

    The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionSep 2010
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00888433
Sponsor's protocol ID
TP-058
Acronym
HTN-2
Status last verified
May 2015
First submitted
24 Apr 2009
Last updated
20 May 2015
Data monitoring committee
Yes

Publications

  • Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.

    PubMed 21093036

  • Xu J, Sesa-Ashton G, Eikelis N, Walton A, Lambert EA, Esler MD, Kiuchi MG, Carnagarin R, Lambert GW, Schlaich MP. Increased plasma levels of erythropoietin after renal denervation in patients with resistant hypertension. Hypertens Res. 2025 Oct;48(10):2631-2640. doi: 10.1038/s41440-025-02317-6. Epub 2025 Aug 14.

    PubMed 40813485

  • Eikelis N, Hering D, Marusic P, Duval J, Hammond LJ, Walton AS, Lambert EA, Esler MD, Lambert GW, Schlaich MP. The Effect of Renal Denervation on Plasma Adipokine Profile in Patients with Treatment Resistant Hypertension. Front Physiol. 2017 May 30;8:369. doi: 10.3389/fphys.2017.00369. eCollection 2017.

    PubMed 28611687

  • Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.

    PubMed 26873693

  • Esler MD, Bohm M, Sievert H, Rump CL, Schmieder RE, Krum H, Mahfoud F, Schlaich MP. Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. Eur Heart J. 2014 Jul;35(26):1752-9. doi: 10.1093/eurheartj/ehu209. Epub 2014 Jun 4.

    PubMed 24898552

  • Mahfoud F, Ukena C, Schmieder RE, Cremers B, Rump LC, Vonend O, Weil J, Schmidt M, Hoppe UC, Zeller T, Bauer A, Ott C, Blessing E, Sobotka PA, Krum H, Schlaich M, Esler M, Bohm M. Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation. 2013 Jul 9;128(2):132-40. doi: 10.1161/CIRCULATIONAHA.112.000949. Epub 2013 Jun 18.

    PubMed 23780578

  • Esler MD, Krum H, Schlaich M, Schmieder RE, Bohm M, Sobotka PA; Symplicity HTN-2 Investigators. Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012 Dec 18;126(25):2976-82. doi: 10.1161/CIRCULATIONAHA.112.130880.

    PubMed 23248063

  • Ukena C, Mahfoud F, Kindermann I, Barth C, Lenski M, Kindermann M, Brandt MC, Hoppe UC, Krum H, Esler M, Sobotka PA, Bohm M. Cardiorespiratory response to exercise after renal sympathetic denervation in patients with resistant hypertension. J Am Coll Cardiol. 2011 Sep 6;58(11):1176-82. doi: 10.1016/j.jacc.2011.05.036.

    PubMed 21884958

  • Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, Hoppe UC, Vonend O, Rump LC, Sobotka PA, Krum H, Esler M, Bohm M. Effect of renal sympathetic denervation on glucose metabolism in patients with resistant hypertension: a pilot study. Circulation. 2011 May 10;123(18):1940-6. doi: 10.1161/CIRCULATIONAHA.110.991869. Epub 2011 Apr 25.

    PubMed 21518978

  • Schlaich MP, Straznicky N, Grima M, Ika-Sari C, Dawood T, Mahfoud F, Lambert E, Chopra R, Socratous F, Hennebry S, Eikelis N, Bohm M, Krum H, Lambert G, Esler MD, Sobotka PA. Renal denervation: a potential new treatment modality for polycystic ovary syndrome? J Hypertens. 2011 May;29(5):991-6. doi: 10.1097/HJH.0b013e328344db3a.

    PubMed 21358414

Questions about this trial

What is this clinical trial studying?

A study testing Renal Denervation (Symplicity® Renal Denervation System) in people with Uncontrolled Hypertension, run by Medtronic Vascular at 20 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany, United Kingdom, Australia, Austria, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Office Systolic Blood Pressure Reduction (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00888433, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in